Trial Outcomes & Findings for Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery (NCT NCT04220489)

Results Overview

Hydromorphone Patient Care Assistant (PCA) usage during the first 72 hours postoperatively will be recorded. Hydromorphone opioid usage will be assessed and converted to morphine equivalents/24 hour. The higher the values, the worse the outcomes.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

72 hours postoperatively

Results posted on

2024-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine Group Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=113 Participants	0 Participants n=163 Participants	1 Participants n=160 Participants
Age, Categorical >=65 years	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Age, Continuous	44 years STANDARD_DEVIATION 0.0 • n=113 Participants	—	44 years STANDARD_DEVIATION 0.0 • n=160 Participants
Sex: Female, Male Female	0 Participants n=113 Participants	—	0 Participants n=160 Participants
Sex: Female, Male Male	1 Participants n=113 Participants	—	1 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	—	0 Participants n=160 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants	—	0 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	—	0 Participants n=160 Participants
Race (NIH/OMB) Black or African American	0 Participants n=113 Participants	—	0 Participants n=160 Participants
Race (NIH/OMB) White	1 Participants n=113 Participants	—	1 Participants n=160 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants	—	0 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	—	0 Participants n=160 Participants
Region of Enrollment United States	1 Participants n=113 Participants	—	1 Participants n=160 Participants

PRIMARY outcome

Timeframe: 72 hours postoperatively

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Hydromorphone Patient Care Assistant (PCA) usage during the first 72 hours postoperatively will be recorded. Hydromorphone opioid usage will be assessed and converted to morphine equivalents/24 hour. The higher the values, the worse the outcomes.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Post-surgical Hydromorphone Patient Care Assistance (PCA) Opioid Utilization	40 mg morphine equivalents per 24 hours Standard Deviation 0	—

PRIMARY outcome

Timeframe: 72 hours post-operatively

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Post-surgical pain ratings will be measured by the assessment of participant's answers to the Visual Analog Scale (VAS). This measurement is a visual scale from 0-10, 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. The participant will be asked to score pain at its best and worst over the period since they were last asked. Higher scores present a worse outcome. Pain will be monitored every four hours from the time the participant enters the PACU until discharge from the hospital, except during the night when the participant is asleep. The value reported consists of the average of all pain scores collected.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Post-surgical Pain Rating Using the Visual Analog Scale (VAS)	5 units on a scale Standard Deviation 0	—

PRIMARY outcome

Timeframe: 72 hours post-operatively

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Post-surgical opioid utilization will be measured by reviewing participant's electronic medical records and recording opioid usage. Daily opioid usage will be assessed and converted to morphine equivalents/24 hr. The higher the values, the worse the outcomes.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Post-surgical Opioid Utilization Using Electronic Medication Review	40 mg morphine equivalents per 24 hours Standard Deviation 0	—

PRIMARY outcome

Timeframe: 6-week follow-up visit

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Post-surgical opioid utilization will be measured by reviewing participant's electronic medical records and recording opioid usage. Daily opioid usage will be assessed and converted to morphine equivalents/24 hr. The higher the values, the worse the outcomes.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Post-surgical Opioid Utilization Using Electronic Medication Review	4 mg Standard Deviation 0	—

PRIMARY outcome

Timeframe: Screening visit

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Pre-surgical opioid utilization will be measured by the Pain Medication Review Form where patients will record all of the medications they are currently taking.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Pre-surgical Opioid Utilization Using the Pain Medication Review Form	4 count of prescription medications Standard Deviation 0	—

PRIMARY outcome

Timeframe: Screening visit

Population: Data was not collected

Post-surgical pain ratings will be measured by the assessment of participant's answers to the Visual Analog Scale (VAS). This measurement is a visual scale from 0-10, 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores present a worse outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening visit

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Pre-surgical emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression Short Form questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least severe score and 40 being the most severe score. Higher scores present a worse outcome.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Pre-surgical Emotional Distress Related to Depression	27 score on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: Day 10-14 Post-Operative Visit

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Post-surgical emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression Short Form questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least severe score and 40 being the most severe score. Higher scores present a worse outcome. The value reported consists of the average of all questionnaire scores collected between POD 10 and POD 14.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Post-surgical Emotional Distress Related to Depression	14 score on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: 6-week follow-up visit

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Post-surgical emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression Short Form questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least severe score and 40 being the most severe score. Higher scores present a worse outcome.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Post-surgical Emotional Distress Related to Depression	19 score on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: Screening visit

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Pre-surgical emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Anxiety Short Form questionnaire. There are 7 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 7 being the least severe score and 35 being the most severe score. Higher scores present a worse outcome.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Pre-surgical Emotional Distress Related to Anxiety	23 score on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: Day 10-14 Post-Operative Visit

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Post-surgical emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Anxiety Short Form questionnaire. There are 7 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 7 being the least severe score and 35 being the most severe score. Higher scores present a worse outcome. The value reported consists of the average of all questionnaire scores collected between POD 10 and POD 14.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Post-surgical Emotional Distress Related to Anxiety	16 score on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: 6-week follow-up visit

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Post-surgical emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Anxiety Short Form questionnaire. There are 7 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 7 being the least severe score and 35 being the most severe score. Higher scores present a worse outcome.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Post-surgical Emotional Distress Related to Anxiety	19 score on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: Screening visit

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Pre-surgical satisfaction with social roles and activities will be measured by assessment of participant's answers to the Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least satisfaction score and 40 being the most satisfaction score. Higher scores present a better outcome.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Pre-surgical Satisfaction With Social Roles and Activities	19 score on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: Day 10-14 Post-Operative Visit

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Post-surgical satisfaction with social roles and activities will be measured by assessment of participant's answers to the Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least satisfaction score and 40 being the most satisfaction score. Higher scores present a better outcome. The value reported consists of the average of all questionnaire scores collected between POD 10 and POD 14.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Post-surgical Satisfaction With Social Roles and Activities	21 score on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: 6-week follow-up visit

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Post-surgical satisfaction with social roles and activities will be measured by assessment of participant's answers to the Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale is from 1, never have felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The questionnaire scores can be from a range of 8 being the least satisfaction score and 40 being the most satisfaction score. Higher scores present a better outcome.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Post-surgical Satisfaction With Social Roles and Activities	20 score on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: Screening visit

Population: Data not collected

Pre-surgical pain ratings will be measured by the assessment of participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 10-14 Post-Operative Visit

Population: Data not collected

Post-surgical pain ratings will be measured by the assessment of participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6-week follow-up visit

Population: Data not collected

Post-surgical pain ratings will be measured by the assessment of participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening visit

Population: Only one subject was enrolled in this study and they were assigned to the ketamine group, therefore, no subjects are analyzed in the placebo group

Pre-surgical opioid analgesic efficacy will be measured by the results of the Cold-Pressor Pain Sensitivity Test, where the participant will submerge their hand in ice water for up to four minutes at thirty minutes before and thirty minutes after the participant's opioid pain medication is taken. Pain tolerance is defined as the time in seconds that it takes for the participant to withdraw their hand from the ice water. Pain threshold, tolerance and cut-off will be recorded using a stopwatch. The McGill Pain Questionnaire short form will be completed after each test. Opioid-analgesic efficacy will be estimated by the change in pain threshold and tolerance observed after the opioid was consumed relative to initial assessment of pain threshold and tolerance. The higher the tolerance after opioid consumption, the better the outcomes.

Outcome measures

Outcome measures
Measure	Ketamine Group n=1 Participants Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.	Placebo Group Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure). Placebo Comparator: Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
Pre-surgical Opioid Analgesic Efficacy Using the Cold-Pressor Pain Sensitivity Test	19.49 seconds Standard Deviation 0.98	—

SECONDARY outcome

Timeframe: 6-week follow-up visit

Population: Data not collected

Post-surgical opioid analgesic efficacy will be measured by the results of the Cold-Pressor Pain Sensitivity Test, where the participant will submerge their hand in ice water for up to four minutes at thirty minutes before and thirty minutes after the participant's opioid pain medication is taken. Pain tolerance is defined as the time in seconds that it takes for the participant to withdraw their hand from the ice water. Pain threshold, tolerance and cut-off will be recorded using a stop watch. The McGill Pain Questionnaire short form will be completed after each test. Opioid-analgesic efficacy will be estimated by the change in pain threshold and tolerance observed after the opioid was consumed relative to initial assessment of pain threshold and tolerance. The higher the threshold and tolerance after opioid consumption, the better the outcomes.

Outcome measures

Outcome data not reported

Adverse Events

Ketamine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jacques E. Chelly, MD, PhD, MBA

UPMC

Phone: 412-623-6904

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60